Penile Length Maintenance Post-Prostatectomy



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/19/2018
Start Date:March 23, 2018
End Date:March 23, 2021
Contact:Leanne Sandieson
Email:sandieson.leanne@mayo.edu
Phone:507-293-2471

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The objective of the current study is to evaluate the efficacy of a novel, class I (ie.
lowest risk, clinical studies not required) medical penile traction device in preventing loss
of penile length in men undergoing robotic-assisted prostatectomy.

The treatment of prostate cancer results in several known sexual dysfunctions, including
erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature
(Peyronie's disease), and reduced penile length. Among the dysfunctions, loss of penile
length is often one that results in significant distress and bother to patients. Beyond the
esthetic concerns, reduced penile length may lead to inability to participate in sexual
intercourse, difficulty with future interventions to restore erectile function, and lead to
worsened urinary hygiene.

Penile traction therapy (PTT) is currently the best available treatment to maintain or
restore lost penile length due to conditions that reduce length. To date, no studies have
evaluated the benefits of using PTT in this clinical setting. The objective of the current
study is to evaluate the efficacy of a novel penile traction device (RestoreX®), created and
funded through Mayo Ventures, in maintaining or restoring reduced penile length.

To accomplish the study, a population of men from Mayo Clinic who have undergone a
prostatectomy will be enrolled and randomized to utilize the device for varying amounts of
time. Outcomes will be assessed at 6 and 9 months post-prostatectomy and results are to be
used with the intent to publish in a scientific journal.

Inclusion Criteria:

- Undergoing robotic prostatectomy

- Seen in the post-prostatectomy rehab clinic

Exclusion Criteria:

• Urethral complications from prostatectomy at the time of baseline visit
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-293-2471
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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